Utah Admin. Code R156-17b-617e - Class E Pharmacy Operating Standards - Human Clinical Investigational Drug Research Facility
(1) Under Section
58-17b-302 and Subsection
58-17b-601(1), a
human clinical investigational drug research facility licensed as a Class E
pharmacy shall, in addition to the requirements in Section
R156-17b-617a, conduct
operations in accordance with the operating standards set forth in 21 CFR Part
312, April 1, 2012 edition, which is incorporated by reference.
(2) Under Subsections
58-37-6(2)(b) and
(3)(a)(i), persons licensed to conduct
research in Utah with controlled substances in Schedules I-V may possess,
manufacture, produce, distribute, prescribe, dispense, administer, conduct
research with, or perform laboratory analysis upon those substances to the
extent authorized by their license.
(3) Under Subsection
58-37-6(2), the
following persons are not required to obtain a license and may lawfully possess
controlled substances in Schedules II-V:
(a)
an agent or employee acting in the usual course of the person's business or
employment, and
(b) an ultimate
user, or a person who possesses a controlled substance pursuant to a lawful
order of a practitioner.
(4) A separate license is required at each
principal place of business or professional practice where the applicant
manufactures, produces, distributes, dispenses, conducts research with, or
performs laboratory analysis upon controlled substances.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.